> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# miR Scientific Gain ‘Breakthrough’ for Prostate Assay
- URL: https://www.fdaweb.com/mir-scientific-gain-breakthrough-for-prostate-assay/
- Published: 2020-10-13T12:00:00.000Z
- Updated: 2026-09-14T16:32:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147864

FDA has granted miR Scientific a Breakthrough Device Designation for its miR Sentinel PCC4 Assay, a prostate test that offers a new method to analyze small non-coding RNAs derived from a urine specimen from age-eligible men. The company says the test uses a “statistical classification algorithm” to score patients according to the likelihood of being in the following four possible groups: no molecular evidence of prostate cancer; low-risk; intermediate-risk; or high-risk prostate cancer. Initial validation data for the assay was published in the September 2020 issue of [*The Journal of Urology*](https://c212.net/c/link/?t=0&l=en&o=2948209-1&h=806924212&u=https%3A%2F%2Fwww.auajournals.org%2Fdoi%2F10.1097%2FJU.0000000000001020&a=The+Journal+of+Urology&ref=fdaweb.com). The company says it will initially commercialize its test as a laboratory-developed test in the U.S.